InspireMD Appoints Principal Investigators for C-GUARDIANS II Clinical Trial of the SwitchGuard™ Neuroprotection System
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Insights
The appointment of principal investigators for the C-GUARDIANS II clinical trial represents a pivotal step in the advancement of InspireMD's SwitchGuard™ Neuroprotection System (NPS). This system's unique capability to reverse cerebral blood flow during Transcarotid Artery Revascularization (TCAR) procedures is a significant innovation in stroke prevention. With stroke being a leading cause of death and long-term disability, the development and potential approval of such a system could have profound implications for patient outcomes and healthcare costs.
From a research standpoint, the involvement of recognized vascular surgery experts suggests a rigorous and credible trial process, potentially increasing the likelihood of successful trial outcomes and subsequent regulatory approval. This could lead to increased market share for InspireMD in the carotid implant space, particularly if the SwitchGuard™ system demonstrates superior efficacy or safety compared to existing alternatives.
The initiation of the C-GUARDIANS II clinical trial is a strategic move for InspireMD, as it seeks to solidify its position in the carotid revascularization market. The trial's success could facilitate the clearance of the SwitchGuard™ NPS, which would enable the company to capitalize on the growing demand for innovative solutions in stroke prevention. The carotid stenting market is expected to grow due to an aging population and an increased prevalence of cardiovascular diseases.
Investors should monitor the progress of this trial closely, as positive outcomes could lead to an uptick in InspireMD's stock value, given the potential expansion of their product portfolio and the enhancement of their competitive edge. Conversely, any setbacks could pose risks to the company's growth trajectory and investor confidence.
The announcement of the C-GUARDIANS II clinical trial by InspireMD is likely to be scrutinized by investors for its potential impact on the company's financial health. The development of the SwitchGuard™ NPS could lead to significant R&D expenses in the short term. However, if the trial is successful and leads to FDA clearance, it could result in substantial revenue growth and enhance the company's profitability in the long term.
Given that InspireMD operates within a highly specialized and regulated market, the successful commercialization of SwitchGuard™ NPS could also lead to strategic partnerships or acquisition interest from larger industry players, which would have a direct influence on shareholder value.
Development of SwitchGuard™ consistent with Company’s mission to uniquely support both Carotid Artery Stenting (CAS) and Transcarotid Artery Revascularization (TCAR) procedures with best-in-class carotid implant and platform
TEL AVIV, Israel and MIAMI, Feb. 12, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that the Company has appointed principal investigators (PIs) for its upcoming C-GUARDIANS II clinical trial of the SwitchGuard™ Neuroprotection System (NPS). Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, have enthusiastically agreed to act as lead PIs for the trial.
Additionally, William Gray, M.D., system chief of the cardiovascular division at Main Line Health in Wynnewood, PA and professor of medicine at Thomas Jefferson University in Philadelphia, PA, will act as an advisor to the Company.
Marvin Slosman, chief executive officer of InspireMD, stated, “As the only company with a mission to develop solutions that support both CAS and TCAR carotid revascularization procedures with a best-in-class implant, we consider initiation of the C-GUARDIANS II clinical trial of our SwitchGuard™ Neuroprotection System as a very significant upcoming milestone for our company. We are very pleased that Drs. Geraghty and Muck, both recognized leaders in the field of vascular surgery, have agreed to lead the execution of this important trial, planned to start later this year. We also welcome William Gray, M.D., as an advisor to the Company and look forward to his contributions given his vast experience and knowledge in the field of carotid intervention.”
“We are very fortunate and grateful to have built an incredible a team of supporters and advocates for C-GUARDIANS II, as we did with the previously enrolled C-GUARDIANS trial, advancing our goal of establishing CGuard Prime as the leading carotid implant.”
The C-GUARDIANS II study is intended to advance clearance of SwitchGuard™ NPS and associated tools, designed to allow the treating physician to reverse cerebral blood flow during a TCAR procedure, thus preventing embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter housed within the SwitchGuard™ before returning it to the patient to minimize blood loss.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS II trial, including the timing of its commencement. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com
FAQ
What is the purpose of the C-GUARDIANS II clinical trial announced by InspireMD, Inc. (NSPR)?
Who are the principal investigators appointed by InspireMD, Inc. (NSPR) for the C-GUARDIANS II trial?
What role will William Gray, M.D., play in the C-GUARDIANS II trial conducted by InspireMD, Inc. (NSPR)?
What is the significance of the SwitchGuard™ Neuroprotection System developed by InspireMD, Inc. (NSPR)?
